Novartis has announced that new data has been published in the peer-reviewed journal Neurology and Therapy focusing on the impact of COVID-19 infections in people living with relapsing remitting multiple sclerosis (RRMS) who have been treated with Kesimpta (ofatumumab).
Kesimpta is the first subcutaneous B-cell therapy that can be self-administered at home for people with RRMS.
Of the 1,703 participants, 245 (14.3%) reported COVID-19, most cases were mild (44.1%) or moderate (46.5%), and the vast majority of patients recovered (98.4%), which is in line with rates seen in the general population.
The overall fatal outcome (0.8%) and hospitalisation rates (9.4%) due to COVID-19 in Kesimpta-treated patients were lower than the rates reported in the overall MS population.
The data was gathered from the ALITHIOS study – an ongoing, long-term extension phase 3b trial – and from reports submitted via the Novartis Global Safety Database.
Dr David Paling, consultant neurologist at the Royal Hallamshire Hospital, said: “COVID-19 has had a huge impact on people living with MS and has complicated decisions about treatment. This study of the outcomes of people who developed COVID-19 while on ofatumumab from the ALITHIOS study will allow my colleagues and I to reassure people with MS about their risks, and have informed discussions about treatment choices based on really accurate evidence.”
In the UK, there are an estimated 130,000 people with MS, with around 7,000 people being newly diagnosed with the condition each year.
David Martin, chief executive officer, Multiple Sclerosis Trust: “Access to a range of different treatment options is important for people living with MS to manage their condition in a way that is best for them and their lifestyle. This data gives reassurance to the MS community that the risk of severe COVID-19 infection in those vaccinated is in line with that reported currently in the general population.”
MS is a life-long, chronic disorder affecting the central nervous system (CNS), disrupting regular brain function, optic nerves and the spinal cord through tissue loss and inflammation. As MS progresses, people living with the condition experience an increasing loss of both physical and cognitive functions.
For those patients diagnosed with relapsing forms of MS (RMS) – including RRMS and secondary progressive MS (SPMS) with active disease – episodic attacks of symptoms are common and are known as relapses.
Approximately 85% of people are considered to have RRMS at their point of diagnosis, while SPMS, which typically follows from an initial RRMS course, presents as a gradual deterioration in neurological function over time.